Drug factory · FDA FEI 1150053
Roberts Oxygen Company, Inc.
17011 Railroad Street, Gaithersburg, MD, United States
Problems found, fixed voluntarily at FDA's last inspection, Dec 12, 2019.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2011: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Carbon Dioxide | Makes it | Roberts Oxygen Company, Inc. | 46123-050, 46123-240 |
| Carbon Dioxide and Oxygen | Makes it | Roberts Oxygen Company, Inc. | 46123-120, 46123-123, 46123-124 +12 |
| Helium | Makes it | Roberts Oxygen Company, Inc. | 46123-800 |
| Nitrogen | Makes it | Roberts Oxygen Company, Inc. | 46123-003, 46123-004, 46123-440 |
| Nitrous Oxide | Makes it | Roberts Oxygen Company, Inc. | 46123-006, 46123-007, 46123-700 |
| Oxygen | Makes it | Roberts Oxygen Company, Inc. | 46123-001, 46123-002, 46123-045 +13 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 12, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Oct 3, 2016 | No problems found | Drug Quality Assurance | — |
| Dec 16, 2011 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Dec 12, 2019 inspection
- Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
Registered with FDA for: manufacture.